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NCT01477866 Clinical Trial

Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer

Colonic Neoplasms Clinical Trial

— CITOGENEX PA  

Official title:
Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT01477866
Other study ID # CITOGENEX CRC
Secondary ID
Status Suspended
Phase N/A
First received November 18, 2011
Last updated December 9, 2017

Study information
Verified date December 2017
Source University of Palermo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main aim of the present study is to test the efficacy and safety of CITOGENEX administration in patients with colon-rectal cancer.

Description:

CITOGENEX is a dietary supplement of insoluble polysaccharides, of Lactobacillus Casei (specific type) and of Bifidobacterium Lactis (specific type). These subspecies of probiotics bacteria have been shown to be effective in improving the immunity. Several trials are currently underway, in order to evaluate the effects of probiotics as potential novel therapies in addition to traditional therapeutic approaches. Although probiotics do not play an anti-tumor action per se, these agents may significantly contribute to decrease the typical side effects due to traditional anti-tumor treatments, such as gastrointestinal symptoms, immunity deficit, as well as the alterations in the gut lymphoid tissue.

It is therefore expected that CITOGENEX may have several significant beneficial effects in patients under anti-tumor treatments. In order to test this hypothesis, we will perform a randomized, single-blind, two-arms, prospective study in patients with colon-rectal cancer.

Recruitment information / eligibility
Status Suspended
Enrollment 250
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria:

- stage IIIa-IIIc (AJCC/TNM)

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• citogenex
CITOGENEX is a dietary supplement of insoluble polysaccharides, of Lactobacillus Casei (specific type) and of Bifidobacterium Lactis (specific type).
Other:
• conventional therapy
conventional therapy for colon-rectal cancer

Locations
Country Name City State
Italy University of Palermo Palermo PA

Sponsors (1)
Lead Sponsor Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary All cause mortality 2 years
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